Multidisciplinary Intervention for Mild Cognitive Impairment ((MCI))

Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases

The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).

Study Overview

• Status: Active, not recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Cognitive training; Dietary supplement: Nutrition

Detailed Description

Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from a combination of optimized diet, exercise, nutritional supplements, and cognitive training across domains on standardized measures used to monitor treatment effectiveness for Mild Cognitive Impairment (MCI).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80919
      • Gibson Institute of Cognitive Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 50+ previously diagnosed with MCI
• Living in the greater Colorado Springs area

Exclusion Criteria:

• No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition and Cognitive Training; The intervention includes a physician-directed diet, exercise, and nutritional supplementation regimen, combined with a 60-hour, clinician-delivered cognitive training program created by LearningRx.	Behavioral: Cognitive training; A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.; Dietary supplement: Nutrition; Participants will be given dietary recommendations and nutritional supplements to optimize cognition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of overall cognitive function improvement	Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)	within 14 days after completing the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of improvement in visual attention	Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)	with 14 days after completing the intervention
Evidence of improvement in auditory attention	Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)	with 14 days after completing the intervention
Evidence of improvement in executive function	As confirmed by pretest to post-test changes on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)	within 14 days after completing the intervention
Evidence of improvement in cognitive flexibility	As confirmed by pretest to post-test changes on a Trail Making Test	within 14 days after completing the intervention
Evidence of change in brain function	Confirmed by change in pretest to post-test neuroimaging using MRI	within 30 days after completing the intervention

Collaborators and Investigators

• Sponsor: Gibson Institute of Cognitive Research
• Collaborators: True Life Medicine
• Investigators: Principal Investigator: Christina Ledbetter, PhD, Gibson Institute of Cognitive Research; Study Director: Amy L Moore, PhD, Gibson Institute of Cognitive Research; Principal Investigator: Dick M Carpenter, PhD, University of Colorado, Colorado Springs; Principal Investigator: Randolph James, MD, True Life Medicine

Publications and helpful links

General Publications

• James, R., Moore, A.L., Carpenter, D., Miller, T., & Ledbetter, C. (2019). Feasibility of a Functional Medicine Approach to Slowing Clinical Cognitive Decline in Patients Over Age 55: A Multiple Case Study Report. OBM Integrative and Complementary Medicine, 4(3). doi: 10.21926/obm.icm.1903054 Retrieved from https://www.lidsen.com/journals/icm/icm-04-03-054

Helpful Links

• James et al study link

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: GICR-1012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Harvard Dataverse